Shake-up of EU medical device regulations shocks industry

MedTech leaders say proposals published this week will have negative effect on the market

The European Commission has outlined controversial plans to overhaul the current regulatory system for the approval of medical devices

Industry leaders have hit out at the European Commission’s plans to overhaul the regulatory system for medical devices, claiming the proposals will ‘fundamentally change the way that products are brought to market without having a positive impact on patient safety’.

The comments come just days after the EU published the details of its intention to revise the current regulatory frameworks for medical devices, which were last altered in the 1990s. The move comes in the wake of the PiP breast implant scandal and concerns over metal-on-metal hip replacement products.

The existing regulatory framework has demonstrated its merits, but has also come under harsh criticism

But, despite MedTech industry representatives widely welcoming a review of the current system for awarding CE mark approval for products being sold in Europe and Turkey, they have been heavily critical of some of the plans laid out in the 194-page draft directive from Brussels.

Mike Kreuzer, executive director of technical and regulatory affairs for the trade body, the Association for British Healthcare Industries (ABHI), told BBH: “The medical device industry has long called for the overhaul of the medical device directives. We set out our position in our evidence to the science and technology committee earlier this year and we have worked with policymakers in Europe and the UK throughout the consultation process.

“Recently a number of high-profile events have shaken public confidence in the system and it is crucial that both industry and policy makers begin rebuilding this trust by improving the system and ensuring that issues such as the PiP scandal never happen again.

Recently a number of high-profile events have shaken public confidence in the system and it is crucial that both industry and policy makers begin rebuilding this trust by improving the system and ensuring that issues such as the PiP scandal never happen again

“At the same time as tightening up the system and improving issues such as transparency and vigilance, policymakers must also make sure that patients are able to access innovative new treatments at the appropriate time. Creating a system that causes unnecessary delays in products coming into the market will harm patients by limiting access to new treatments.

“The new procedure will fundamentally change the way that products are brought to market without having a positive impact on patient safety.”

The criticism mainly concerns the proposed new powers of scrutiny that will be given to regulators, enabling authorities to take a second look at individual assessments of products and to make their views known before a device is placed on the market.

The concerns are shared by the pan-European industry trade body, Eucomed. It said in a statement this week that the scrutiny procedure would ‘ultimately harm patients and negatively impact European governments and industry'.

In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the directives, i.e. the safety of medical devices and their free movement within the internal market

The changes affect both the current directive on active implantable medical devices and the directive on medical devices, which cover a huge spectrum of products. The current system divides products into four classes of risk: Class I is low-risk things such as sticking plasters and corrective glasses; Class IIa covers medium to low-risk items such as dental filling material and tracheal tubes; Class IIb is for medium to high-risk devices such as X-ray machines and bone plates and screws; and Class III is for high-risk instruments such as pacemakers and implantable defibrillators.

At present devices are subjected to a conformity assessment, which for medium and high-risk items involves an independent third party, known as a Notified Body. In the wake of the PiP scandal, the spotlight fell on these organisations, with criticism that they were operating to different standards across Europe and that their decisions and actions were not being properly scrutinised.

The EU proposal states: “The existing regulatory framework has demonstrated its merits, but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer, Poly Implant Prothèse (PiP), had for several years apparently used industrial silicone instead of medical-grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.

A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry

“In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the directives, i.e. the safety of medical devices and their free movement within the internal market. Moreover, regulatory gaps or uncertainties exist with regard to certain products (e.g. products manufactured utilising non-viable human tissues or cells; implantable or other invasive products for cosmetic purposes.
“This revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices to the benefit of patients and healthcare professionals.”

The main changes proposed to the current system are:

Wider, clearer scope extended to include, for example, implants for aesthetic purposes and clarified as regards to genetic tests

Stronger supervision of Notified Bodies by national authorities

More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections

Clearer rights and responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales

An extended European database on medical devices with Eudamed providing comprehensive information on products available on the EU market. Non-confidential data will also be publicly available

Better traceability of medical devices throughout the supply chain, enabling a swift and effective response to safety problems (e.g. recalls)

Stricter requirements for clinical evidence to support assessments of medical devices

Updated classification rules that devide medical devices into four different risk categories and health and safety requirements, including new labelling rules, to keep pace with technological and scientific progress

Better co-ordination between national surveillance authorities, with the European Commission providing scientific, technical and logistic support

Existing international guidelines to be incorporated into EU law

The new procedure will fundamentally change the way that products are brought to market without having a positive impact on patient safety

The proposal is adopted alongside a second document covering revisions in vitro diagnostic devices, such as blood tests.

Commenting on the wider impact of the proposals, Kreuzer said: “ABHI welcomes many of the changes, such as stricter controls and monitoring of Notified Bodies, increased co-ordination on vigilance, and the establishment of a comprehensive registration database accessible by Governments and patients. These measures will help make the system more transparent and will improve the overall safety of patients in the UK.”

The proposals will now have to pass through the formal EU legislative procedure, with agreement needed between the European Parliament and the Council of Ministers. Once adopted, they will replace the existing directives.